Senior/Executive Director, Head of Quality

About the Company

Emerging biotechnology (BioTech) firm specializing in innovative therapeutics for serious musculoskeletal diseases

Industry Pharmaceuticals

Type Privately Held

Founded 2018

Employees 51-200

Categories

Pharmaceuticals Biotechnology Health Care Academic Research Medical Conditions Therapeutics Clinical Care Health International Business Manufacturing Medicine Chemical Products

Specialties

musculoskeletal rare diseases bone cartilage and muscle

About the Role

The Company is in search of a Senior/Executive Director, Head of Quality to oversee all GxP Quality functions, including Quality Assurance, Quality Control, R&D Quality, Document Control, Supplier Quality, and Quality Systems. The successful candidate will be responsible for defining and driving the company's quality vision, ensuring global compliance, and supporting programs from early development to commercialization. This role requires a leader with deep expertise in large molecule and aseptic manufacturing, regulatory requirements, and global vendor oversight. The Head of Quality will also be tasked with building and optimizing scalable Quality Systems, leading major deviation investigations, and managing cross-functional teams in a dynamic environment.

Applicants must have a Bachelor's or Master's degree in a scientific discipline, with at least 12 years of industry experience, and a strong background in Quality Assurance. The ideal candidate will have a proven track record in building Quality Systems, experience with U.S. and international CDMOs, and a deep understanding of GxP regulations. Strong leadership, mentoring, and problem-solving skills are essential, as is bilingual fluency in English and Mandarin. The role involves leading and hosting regulatory inspections, overseeing Quality Agreement negotiations, and managing budget and cost optimization. The Head of Quality will also be expected to partner with Regulatory Affairs for global submissions and ensure the company's readiness for regulatory inspections.

Hiring Manager Title Chief Technology Officer

Travel Percent 20%

Functions

CEO/President Non-Profit Management Operations General Management Strategy